Early first-trimester sibutramine exposure : pregnancy outcome and neonatal follow-up.

BACKGROUND: Sibutramine is a drug that is used in the treatment of obesity. There are currently no epidemiological studies relating to sibutramine exposure in pregnancy. The objective of our study was to determine whether sibutramine exposure during pregnancy constitutes a risk factor to the mother and developing fetus.

METHODS: Fifty-two pregnant women who were exposed to sibutramine in the first trimester of pregnancy, when they were unaware of being pregnant, contacted our Teratology Information Service. We recorded the prospective outcomes of this case series between May 2001 and September 2004 with a complete neonatal follow-up up to 1 month after delivery.

RESULTS: Seven cases of hypertensive complications were observed during pregnancies. No cases of congenital anomalies in neonates were observed.

CONCLUSION: Although many more cases are necessary to demonstrate that sibutramine is not teratogenic in pregnancy, our experience improves the counseling of pregnancies occurring involuntarily during sibutramine therapy.